McNeil-Williams v. DePuy Orthopaedics, Inc.
McNeil-Williams v. DePuy Orthopaedics, Inc.
Opinion of the Court
This matter is before the court on defendants' motion for summary judgment (DE 28).
STATEMENT OF THE CASE
Plaintiff commenced this products liability action in Harnett County Superior Court, on April 13, 2018, arising out of injuries she allegedly suffered as a result of insertion of a defective knee implant device (the "Product"). Plaintiff allegedly experienced severe pain and discomfort following the insertion of the Product and underwent a revision surgery due to the failure of the Product.
Plaintiff asserts negligence claims against defendants on the basis that they failed to exercise reasonable care in the design, research, manufacture, marketing, testing, advertisement, supply, promotion, packaging, sale, and distribution of the Product. She also asserts defendants failed to exercise due care in the labeling of the Product and failed to issue to consumers and healthcare providers adequate warnings of the risk of serious bodily injury resulting from its use.
Defendants removed the case on May 18, 2018, and answered on May 25, 2018. On August 31, 2018, following the parties' submission of individual reports and discovery plans pursuant to Federal Rule of Civil Procedure 26(f), and following a telephonic scheduling conference before a magistrate judge, the court entered case management order allowing defendants to file a summary judgment motion on the ground that all claims are preempted by federal law, and staying discovery pending entry of an order disposing of the motion.
On October 15, 2018, plaintiff filed the instant motion to vacate the court's August 31, 2018, order staying discovery. That same date, defendants filed the instant motion for summary judgment, relying upon a memorandum in support, statement of material facts, and a declaration of Kathy J. Brocato ("Brocato"), which incorporates and describes business records maintained by defendant DePuy Orthopaedics, Inc. ("DePuy"), including medical records of the Product that is the subject of the instant dispute, and the history of regulation and pre-market approval of the Product by the United States Food and Drug Administration ("FDA").
*573Plaintiff filed the instant motion for discovery, as corrected, on December 3, 2018, relying upon a memorandum of law, which is identical in substance to her memorandum in opposition to summary judgment, filed separately on November 19, 2018. In support thereof, plaintiff relies upon a declaration by counsel for plaintiff, Margaret E. Cordner ("Cordner"), as well as proposed interrogatories and requests for production of documents. Defendants responded in opposition to the motion for discovery and replied in support of summary judgment.
On March 15, 2019, the court directed the parties to submit supplemental briefing, in light of the decision by the United States Court of Appeals for the Fourth Circuit in Burrell v. Bayer Corp.,
STATEMENT OF UNDISPUTED FACTS
As pertinent to the instant motion, the undisputed facts may be summarized as follows.
COURT'S DISCUSSION
A. Standard of Review
Summary judgment is appropriate where "the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). The party seeking summary judgment "bears the initial responsibility of informing the district court of the basis for its motion, and identifying those portions of [the record] which it believes demonstrate the absence of a genuine issue of material fact." Celotex Corp. v. Catrett,
Only disputes between the parties over facts that might affect the outcome of the case properly preclude entry of summary judgment. See Anderson v. Liberty Lobby, Inc.,
Nevertheless, "permissible inferences must still be within the range of reasonable probability, ... and it is the duty of the court to withdraw the case from the [factfinder] when the necessary inference is so tenuous that it rests merely upon speculation and conjecture." Lovelace v. Sherwin-Williams Co.,
B. Analysis
Defendants seek summary judgment on the basis that all of plaintiff's claims are preempted by federal law, where it is undisputed that the Product was approved by the FDA. To address the issue raised, the court first sets forth background on preemption law in the context of FDA-approved devices, and then applies that law to the claims plaintiff asserts in this case. Finally, the court addresses plaintiff's motions for discovery.
1. Preemption
The Medical Device Amendments of 1976 (the "MDA") to the Food, Drug, and Cosmetic Act "provides a rigorous, comprehensive, and exclusive framework that precludes state law tort claims that seek to impose different or higher standards upon federally approved devices." Walker v. Medtronic, Inc.,
"The premarket approval process includes review of the device's proposed labeling." Riegel v. Medtronic, Inc.,
Against this backdrop of rigorous premarket approval, the MDA preempts state law claims in two respects. First, the MDA expressly preempts any state law "requirement ... which is different from, or in addition to, any requirement applicable under [the MDA] to the device."
*57521 U.S.C. § 360k(a)(1). The United States Supreme Court has interpreted this provision to mean that "common-law causes of action for negligence and strict liability ... impose 'requirements' and would be pre-empted by federal requirements specific to a medical device." Riegel,
Second, the MDA "impliedly" preempts additional types of state law claims. Buckman Co. v. Plaintiffs' Legal Comm.,
Although the United States Court of Appeals for the Fourth Circuit has not described the operation of these two preemption doctrines together in a published opinion, other circuit courts have recognized that "[t]hese two types of preemption, operating in tandem, have created ... a 'narrow gap' for pleadings" in a medical device products liability case. Mink v. Smith & Nephew, Inc.,
2. Application
Plaintiff's claims fail to escape the foregoing express and implied preemption restrictions in the MDA. In support of her complaint, plaintiff advances primarily a theory of negligence that is based upon breach of a "duty to warn." (Pl's Supp. Mem. (DE 48) at 3-5; Opp. to S.J. (DE 38) at 10-16). She asserts that the MDA does not preempt her state law negligence claim based upon breach of "the duty to provide the FDA with 'Adverse Reaction' and 'Device Defect reports' " and the duty "to report to the FDA" information suggesting "that a device ... may have caused or contributed to a death or serious injury." (Opp. to S.J. (DE 38) at 11; see Pl's Supp. Mem. (DE 48) at 4).
Plaintiff's primary asserted theory of negligence liability fails, however, because North Carolina law does not recognize a parallel duty on manufacturers to report to the FDA as plaintiff asserts. Rather, North Carolina law recognizes a duty to warn only users or medical practitioners in certain circumstances. For example, North Carolina law provides a cause of action for "failure to provide adequate warning or instruction," where "[a]fter the product left the control of the manufacturer or seller, the manufacturer or seller became aware of or in the exercise of ordinary care should have known that the product posed a substantial risk of harm to a reasonably foreseeable user or consumer." N.C. Gen. Stat. § 99B-5(a)(2).
*576Consistent with this statute, the North Carolina Supreme Court has recognized a cause of action for failure "to use proper care to give adequate warning to the user, not only as to dangers arising from unsafe design, or other negligence, but also as to dangers inseparable from a properly made product." Corprew v. Geigy Chem. Corp.,
Plaintiff cites no case, and the court has found none, where North Carolina courts have recognized a duty under North Carolina law to inform the FDA of adverse reactions, defects, and other injury information. Plaintiff cites, instead, to Williams v. Smith & Nephew, Inc.,
Plaintiff also points to a suggestion by the court in Burrell v. Bayer Corp.,
Second, the case upon which Burrell relies for its "independent state-law duty" proposition is a Ninth Circuit case, Stengel v. Medtronic Inc.,
*577
Plaintiff also cites to Carlson v. Bos. Sci. Corp.,
Plaintiff suggests, in addition, that she has asserted a negligence claim premised upon breach of a "duty to ... warranty," in addition to a "duty to warn." (Pl's Supp. Mem. (DE 48) at 3-5; Opp. to S.J. (DE 38) at 10-16). Plaintiff contends that defendants had a duty to "convey an effective warning and warranties." (Pl's Supp. Mem. (DE 48) at 3; Opp. to S.J. (DE 38) at 11) (emphasis added). Plaintiff does not explain, however, how this duty to convey a warranty is any different from a duty to warn, and she suggests that there is no difference by citing only to authorities addressing a duty to warn under North Carolina law. (See
In any event, plaintiff does not assert any warranties that defendants were obligated to convey under North Carolina law that run parallel to MDA requirements, as opposed to different from or in addition to MDA requirements. See Riegel,
In sum, plaintiff's negligence claims as asserted in the instant matter are expressly and impliedly preempted by the MDA. Therefore, defendants are entitled to judgment as a matter of law on such claims. Furthermore, where plaintiff "concedes that other claims in Plaintiff's complaint can be dismissed," (Pl's Supp. Br. (DE 48) at 3), which concession the court considers under the standard for voluntary dismissal of claims under Rule 41(a)(2), plaintiff's remaining claims are dismissed. Such dismissal is with prejudice because the court determines independently that, as a matter of law, all remaining claims asserted in the complaint are preempted. See, e.g., Riegel,
3. Discovery
In her motion to vacate the court's scheduling order and motion for discovery, plaintiff argues she should be allowed a period of discovery on the issue of preemption before the court decides defendants' motion for summary judgment. Plaintiff proposes interrogatories and requests for production related to the design, manufacture, and warnings associated with the Product.
Federal Rule of Civil Procedure 56(d) provides that "[i]f a non-movant shows by affidavit or declaration that, for specified reasons, it cannot present facts essential to justify its opposition, the court may: (1) defer considering the motion or deny it; (2) allow time to obtain affidavits or declarations or to take discovery; or (3) issue any other appropriate order."
In this case, plaintiff has not demonstrated that discovery is essential to justify her opposition to the motion for summary judgment. The court's preemption determination herein turns upon the simple undisputed fact that the Product is a medical device granted premarket approval by the FDA. See Riegel,
Rather, plaintiff seeks discovery "that could be used to challenge the integrity of" FDA's premarket approval of the Product. (Id. ). For example, plaintiff seeks discovery regarding whether defendants' "submissions to the FDA were timely, truthful and complete." (Id. ¶ 12(e)). Plaintiff seeks information regarding Product development, history, reports and warnings, as well as communications about the device with FDA and healthcare providers. (Id. ¶ 13). A challenge to the integrity of FDA's premarket approval of the Product, however, is itself preempted under Buckman. See
In sum, the discovery sought is inapposite to the court's resolution of defendants' motion for summary judgment. Therefore, plaintiff's motion to vacate and motion for discovery must be denied.
CONCLUSION
Based on the foregoing, defendants' motion for summary judgment (DE 28) is GRANTED. Plaintiff's motion to vacate order staying discovery (DE 27) and motion for discovery (DE 43) are DENIED.
*579The clerk is DIRECTED to close this case.
SO ORDERED, this the 28th day of May, 2019.
The court constructively has amended the caption of this order to reflect dismissal by notice of voluntary dismissal previously filed in state court of defendants designated as Zimmer Biomet, Inc., Zimmer Orthopaedic Surgical Products, Inc., Biomet, Inc., Zimmer Biomet Holdings, Inc., and Smith & Nephew, Inc.
As discussed further herein, plaintiff expressly limits her negligence claims to a theory of breach of duty "to warn and warranty." (Pl's Supp. Br. (DE 48) at 3). While plaintiff asserts nine additional claims apart from negligence in her complaint, plaintiff now specifically "concedes that other claims in Plaintiff's complaint can be dismissed." (Id. at 3 (emphasis added)). Claims apart from negligence asserted in the complaint are: "strict products liability: design defect" (Count II); "strict products liability: failure to warn" (Count III); "breach of express warranty" (Count IV); "breach of implied warranty" (Count V); "fraudulent misrepresentation" (Count VI); "fraudulent concealment" (Count VII); "negligent misrepresentation" (Count VIII); "unjust enrichment" (Count IX); and "unfair and deceptive trade practices" (Count X).
Defendants Johnson & Johnson, Johnson & Johnson Services, Inc., and Johnson & Johnson Consumer Companies, Inc., assert that they are not appropriately named parties in this case, but appear specially to join in the instant motion for summary judgment. In the event that defendants' motion is not granted, they reserve the right to seek dismissal at a later date, including on the grounds of personal jurisdiction.
Additional facts viewed in the light most favorable to defendants will be addressed in conjunction with analysis of plaintiff's motion for partial summary judgment.
Reference
- Full Case Name
- Annie MCNEIL-WILLIAMS v. DEPUY ORTHOPAEDICS, INC. n/k/a Medical Device Business Services, Inc. DePuy Synthes Products, Inc. Johnson & Johnson Johnson & Johnson Services, Inc. Johnson & Johnson Consumer Companies, Inc. n/k/a Johnson & Johnson Consumer, Inc. Doe 1-100
- Cited By
- 2 cases
- Status
- Published